Application Sponsors
Marketing Status
| Prescription | 001 |
| Prescription | 002 |
| Prescription | 003 |
Application Products
| 001 | TABLET;ORAL | 300MG;5MG | 0 | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | ACETAMINOPHEN; HYDROCODONE BITARTRATE |
| 002 | TABLET;ORAL | 300MG;7.5MG | 0 | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | ACETAMINOPHEN; HYDROCODONE BITARTRATE |
| 003 | TABLET;ORAL | 300MG;10MG | 0 | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | ACETAMINOPHEN; HYDROCODONE BITARTRATE |
FDA Submissions
| UNKNOWN; | ORIG | 1 | AP | 2017-03-31 | STANDARD |
| REMS; REMS | SUPPL | 5 | AP | 2018-09-18 | |
| LABELING; Labeling | SUPPL | 6 | AP | 2018-09-20 | STANDARD |
| LABELING; Labeling | SUPPL | 7 | AP | 2019-10-11 | STANDARD |
| LABELING; Labeling | SUPPL | 10 | AP | 2021-03-04 | STANDARD |
Submissions Property Types
| ORIG | 1 | Null | 7 |
| SUPPL | 5 | Null | 15 |
| SUPPL | 6 | Null | 7 |
| SUPPL | 7 | Null | 7 |
| SUPPL | 10 | Null | 15 |
TE Codes
| 001 | Prescription | AA |
| 002 | Prescription | AA |
| 003 | Prescription | AA |
CDER Filings
SPECGX LLC
cder:Array
(
[0] => Array
(
[ApplNo] => 206718
[companyName] => SPECGX LLC
[docInserts] => ["",""]
[products] => [{"drugName":"HYDROCODONE BITARTRATE AND ACETAMINOPHEN","activeIngredients":"ACETAMINOPHEN; HYDROCODONE BITARTRATE","strength":"300MG;5MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"HYDROCODONE BITARTRATE AND ACETAMINOPHEN","activeIngredients":"ACETAMINOPHEN; HYDROCODONE BITARTRATE","strength":"300MG;7.5MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"HYDROCODONE BITARTRATE AND ACETAMINOPHEN","activeIngredients":"ACETAMINOPHEN; HYDROCODONE BITARTRATE","strength":"300MG;10MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
[labels] =>
[originalApprovals] => [{"actionDate":"03\/31\/2017","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
[supplements] => [{"actionDate":"10\/11\/2019","submission":"SUPPL-7","supplementCategories":"Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"09\/20\/2018","submission":"SUPPL-6","supplementCategories":"Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"09\/18\/2018","submission":"SUPPL-5","supplementCategories":"REMS - PROPOSAL - D-N-A","inserts":"[]","notes":"> Label is not available on this site."}]
[actionDate] => 2019-10-11
)
)